MAUDE Adverse Event Report: SPINE WAVE, INC. SNIPER® SPINE SYSTEM LOCKING SCREW; PEDICLE SCREW SYSTEM

Catalog Number	11-4001
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The locking screws and pedicle screw were returned for evaluation.Visual examination was performed.All devices exhibited signs of wear consistent with surgical use.The locking screws and pedicle screw threads displayed no abnormalities and performed properly during evaluation.A review of the device history records found no non-conformances to specification.In addition, two tightening instruments were returned for evaluation.These devices performed within design specifications; no visual or functional abnormalities were detected.A review of the device history records found no non-conformances to specification.Based on the results of our evaluation, no definitive conclusions can be drawn.
Event or Problem Description
At routine 6 month follow up, x-ray imaging showed a locking screw at l5 level appeared to be disengaged.The patient was asymptomatic.The surgeon chose to re-instrument due to migration of the interbody device (another manufacturer).The surgeon successfully removed and replaced the loose locking screw and additionally one pedicle screw and locking screw and the interbody device.

• Brand Name: SNIPER® SPINE SYSTEM LOCKING SCREW
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 6211357
• Report Number: 3004638600-2016-00007
• Device Sequence Number: 16498440
• Product Code: MNH
• UDI-Device Identifier: 10840642105599
• UDI-Public: 10840642105599
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: 11-4001
• Device Lot Number: 661P031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention